Z-1316-2023Class II

Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges

Name: Z-1316-2023 Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges
Creator: Baxter Healthcare Corporation
Published: 2023-02-22
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-02-22 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges on 2023-02-22. FDA classified it as Class II and gives the reason as "The electrical safety testing was not properly performed on the impacted devices and additional testing is required". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1316-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-22
Posted: 2023-04-01
Recalling firm: Baxter Healthcare Corporation
Product: Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: The electrical safety testing was not properly performed on the impacted devices and additional testing is required
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Baxter notified consignees via phone call on 02/22/2023. The notification outlined the issue and that Baxter was retrieving the units and then replacing them within 24 hours.
Quantity in commerce: 16 units
Distribution: US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
Product codes and lots: Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1316-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1316-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-30

Product code FKX

K201867Class IIHomechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemBaxter Healthcare Corporation / cleared 2020-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)